Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence, Urgency-frequency Syndrome, Urinary Incontinence, Urinary Incontinence, Urge
Conditions
Brief summary
Overactive bladder (OAB) imposes a significant quality of life, mental health, and economic burdens. OAB with or without Urgency incontinence is associated with depression, sexual dysfunction, and limitation of social interactions and physical activities, which significantly affects quality of life. Non-invasive neuromodulation with repetitive transcranial magnetic stimulation (rTMS) can be used in research settings to investigate responses to focal regional brain activation. In the clinical setting, rTMS normalizes brain activity with associated clinical benefits in conditions such as refractory depression. rTMS has been studied for effects on lower urinary tract symptoms (LUTS) in bladder pain and neurogenic lower urinary tract symptoms (LUTS) populations. Unlike many standard of care OAB interventions, the safety of rTMS is well-reported, including for use in elderly populations and those with cognitive impairment. Functional magnetic resonance imaging (fMRI) to evaluate neuroplasticity is emerging as an essential tool to define OAB phenotypes; however, phenotyping studies guided by mechanistic data are lacking. The effects of central neuromodulation on regions involved OAB mechanisms and associated physiological and clinical responses are unknown. This study will be the first to report neuroplasticity, physiologic, and clinical effects of central neuromodulation with rTMS in adults with OAB.
Detailed description
This prospective trial will enroll eligible adults with OAB recruited from Urology and urogynecology clinics. Subjects have a baseline evaluation with questionnaires, clinical data, and fMRI to assess brain activity during urinary urgency. All subjects receive the intervention: 5 daily sessions of rTMS to regions of interest. Electromyography will assess pelvic floor muscle activity at rest during rTMS. Following the intervention, an evaluation with questionnaires, clinical data, and fMRI is repeated.
Interventions
DEVICETranscranial Magnetic Stimulation
Magstim Rapid2 Therapy System
Sponsors
The Methodist Hospital Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective cohort study, all subjects receive the same intervention
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Females \& Males * 40 to 80 years old * 3 months of OAB symptoms without active urinary tract infection currently * Bladder diary: * Mean voids/24 hours ≥ 8.0 * Mean urgency episodes/24 hours ≥ 3.0 * Montreal Cognitive Assessment (MoCA) score \>10
Exclusion criteria
* Pregnant, nursing, or self-report of planning to become pregnant. * Contraindication to MRI or to the Rapid2 Magstim Device as listed in the operator manual * Qmax \< 10 ml/s in males on uroflow * \< 20th percentile on Liverpool nomogram * Postvoid residual volume ≥ 200 mL, suprapubic or indwelling catheter * Personal or immediate family history of seizure disorder * Taking (bupropion) Wellbutrin or heavy alcohol use * Parkinson's disease, Multiple sclerosis, spinal cord injury * Intracranial lesions and hemorrhagic stroke within the last 12 months * History of interstitial cystitis, pelvic radiation, bladder augmentation * Intradetrusor botulinum toxin injections within 6 months * Pelvic floor therapy within 2 months. * Active/on-mode Sacral nerve stimulator (eligible if turned off) * Incarcerated patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regional brain activity | Post-intervention at: 0 to 3 days | Activity in the supplemental motor area and prefrontal cortex during full bladder |
| Functional connectivity | Post-intervention at: 0 to 3 days | Connectivity of regions of interest with a full bladder and empty bladder state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic floor muscle activity | on day 5 of the intervention | Surface electromyography of the pelvic floor muscles during rTMS sessions with subjects at rest |
| Urinary frequency | Post-intervention at: 1 day, 3 weeks, 6 weeks | Mean Voids per 24 hours (n) 2- day bladder diary (higher score is worse outcome) |
| Urgency episodes | Post-intervention at: 1 day, 3 weeks, 6 weeks | Mean urgency episodes per 24 hours (n) 2- day bladder diary (higher score is worse outcome) |
| OAB Symptom Bother | Post-intervention at: 1 day, 3 weeks, 6 weeks | OAB-q symptom burden score (higher score is worse outcome) |
| OAB related Quality of life | Post-intervention at: 1 day, 3 weeks, 6 weeks | OAB-q health-related quality of life score (higher score is a better outcome) |
Countries
United States
Contacts
STUDY_DIRECTORMichelle Almarez, BBA
Houston Methodist Obstetrics & Gynecology Department
Outcome results
None listed